BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3199122 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-11096
    Event Type
    Injury
    Date Received
    July 1, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3 889-28, LOT# V926179, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE RETENTION AND WAS ¿ALL SWOLLEN UP¿. THE PATIENT¿S LEGS AND BUTT WERE ALL ¿BLOWN UP¿. ADDITIONALLY, THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE REPORTER WAS UNCERTAIN OF THE ONSET OF THE SYMPTOMS. THE REPORTER INDICATED THAT THE PATIENT HAD BEEN ADMITTED TO THE HOSPITAL FOR HER INABILITY TO URINATE. THE PATIENT¿S BLOOD WORK, KIDNEYS AND ULTRASOUND WERE ALL ¿CLEAR¿ AND ALL TEST RESULTS HAD REPORTEDLY COME BACK NEGATIVE. IT WAS UNCLEAR IF ADDITIONAL TESTING WAS BEING DONE AS THE REPORTER INDICATED THAT A CT SCAN AND BLOOD WERE ALSO BEING DONE. THE PATIENT HAD REPORTEDLY HAD MEMORY ISSUES TOO BUT ON THE DAY OF THE REPORT, THE PATIENT WAS ¿CLEAR¿. IT WAS NOTED THAT THE HEALTHCARE PROVIDER (HCP) DID THE IMPLANT WITHOUT ANESTHESIA. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300112 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization